← Back to Search

Monoclonal Antibodies

IMP7068 for Solid Tumors (WEE1 Trial)

Phase 1

Recruiting

Research Sponsored by Impact Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day -7 to repeat dose day 1; postdose at multiple time points from day 1 to day 21 in cycle 1 (cycle 1 = 21 days), day 1 on cycle 2 (cycle 2 onwards = 21 day-cycles) and subsequent cycles (up to 26 months)

Awards & highlights

WEE1 Trial Summary

This trial is testing a new drug to see if it is effective and safe in treating advanced solid tumors.

Eligible Conditions

Advanced Solid Tumors

WEE1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day -7 to repeat dose day 1; postdose at multiple time points from day 1 to day 21 in cycle 1 (cycle 1 = 21 days), day 1 on cycle 2 (cycle 2 onwards = 21 day-cycles) and subsequent cycles (up to 26 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day -7 to repeat dose day 1; postdose at multiple time points from day 1 to day 21 in cycle 1 (cycle 1 = 21 days), day 1 on cycle 2 (cycle 2 onwards = 21 day-cycles) and subsequent cycles (up to 26 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day -7 to repeat dose day 1; postdose at multiple time points from day 1 to day 21 in cycle 1 (cycle 1 = 21 days), day 1 on cycle 2 (cycle 2 onwards = 21 day-cycles) and subsequent cycles (up to 26 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1 Dose Escalation: Incidence of treatment emergent adverse events (TEAEs)

Part 1 Dose Escalation: Recommended Phase 2 Dose (RP2D) of IMP7068 monotherapy

Part 1 Dose Escalation: Severity of treatment emergent adverse events (TEAEs), according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0

+1 more

Secondary outcome measures

Disease

Part 1 Dose Escalation: Duration of response (DOR): duration of time a patient is evaluated as either complete response (CR) or partial response (PR) as best response until the first date that the criteria for progression are met, or death.

Part 1 Dose Escalation: Objective response rate (ORR): percentage of patients who had a best response

+7 more

WEE1 Trial Design

1Treatment groups

Experimental Treatment

Group I: IMP7068Experimental Treatment1 Intervention

Part 1: Dose Escalation The study will begin with open-label dose escalation in IMP7068 monotherapy treatment to determine the Maximum tolerated dose (MTD) Part 2: Dose Expansion The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage. A total of 100 patients each with advanced solid tumor who has exhausted available treatment options will be evaluated.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

CovanceIndustry Sponsor

119 Previous Clinical Trials

12,466 Total Patients Enrolled

Impact Therapeutics, Inc.Lead Sponsor

14 Previous Clinical Trials

1,254 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants enlisted in this experiment?

"This medical trial necessitates 350 eligible patients to participate. Potential participants can locate University of Kansas Clinical Research Center in Fairway, Kansas and Norton Cancer Institute in Louisville, Kentucky as potential sites for participation."

Answered by AI

What are the various locations in which this clinical exploration is being conducted?

"Participating in this research are the University of Kansas Clinical Research Center located in Fairway, Kansas; Norton Cancer Institute situated in Louisville, Kentucky; Mary Crowley Cancer Research based out of Dallas, Texas and 5 additional sites."

Answered by AI

Are there still openings for volunteers to participate in this experiment?

"Records available on clinicaltrials.gov verify that this study is actively enrolling patients, with a first post date of February 25th 2021 and last updated October 24th 2022."

Answered by AI

How reliable is this treatment in terms of patient safety?

"With limited clinical data supporting safety and efficacy, this intervention was assessed as a 1 on our team's scale. This is reflective of its Phase 1 status."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Safety and Pharmacokinetics Preliminary Efficacy of IMP7068 in Patients With Advanced Solid Tumors

2021. "The Safety and Pharmacokinetics Preliminary Efficacy of IMP7068 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04768868.